Factors associated with new onset of depression and anxiety symptoms differ by sex in the COPDGene study.
Authors: Voorhies K, Fiedorowicz JG, Yohannes AM, Kinney GL, DeMeo DL, Regan EA, Crapo JD, Silverman EK, Lange C, Hoth KF, Lutz SM
Journal: Journal of psychosomatic research
mental health
psychology
open access
Abstract
“Do the best you can until you know better. Then when you know better,
do better.” The mission of pediatric psychology is to “actively promote the health and
psychological well-being of children, youth, and
families” (). A primary
contribution of pediatric psychologists is the development, testing, and implementation
of empirically supported psychosocial and behavioral interventions for youth with health
conditions. The success of this mission is based, in part, on the rigorous and ethical
design and evaluation of interventions to ensure that treatments are supported by
science. Intervention research occurs on a spectrum from early development studies
through small proof-of-concept and pilot studies and ultimately, to fully powered
efficacy trials ().
Efficacy trials have largely followed the “gold standard” of randomized
clinical trials (RCTs; ), comparing an intervention of interest to an alternative comparator
condition: treatment as usual, a control condition, or a known efficacious treatment
(). Trial design shapes the value of the data and knowledge generated. It is critical
to consider how we can improve trial design with greater attention to both scientific
rigor (i.e., use of the scientific method to conduct well-controlled experiments) and
equity (i.e., fair and just distribution of resources and access). Therefore, the
current paper addresses one component of intervention research design: choosing a
comparator condition in clinical trials and other intervention studies in pediatric
psychology. The current paper aims to guide researchers to consider rigor and equity in
their selection of (1) trial design (i.e., whether a comparator condition is necessary),
and (2) the comparator condition itself (i.e., if a comparator condition is deemed
necessary, how to address both rigor and equity in the selection process). Previous work
has described processes for selecting comparator conditions with a focus on scientific
rigor (), but equity
considerations were not included. We advance the literature by considering both
scientific rigor and equity in trial design, with a focus on the selection of comparator
conditions.
do better.” The mission of pediatric psychology is to “actively promote the health and
psychological well-being of children, youth, and
families” (). A primary
contribution of pediatric psychologists is the development, testing, and implementation
of empirically supported psychosocial and behavioral interventions for youth with health
conditions. The success of this mission is based, in part, on the rigorous and ethical
design and evaluation of interventions to ensure that treatments are supported by
science. Intervention research occurs on a spectrum from early development studies
through small proof-of-concept and pilot studies and ultimately, to fully powered
efficacy trials ().
Efficacy trials have largely followed the “gold standard” of randomized
clinical trials (RCTs; ), comparing an intervention of interest to an alternative comparator
condition: treatment as usual, a control condition, or a known efficacious treatment
(). Trial design shapes the value of the data and knowledge generated. It is critical
to consider how we can improve trial design with greater attention to both scientific
rigor (i.e., use of the scientific method to conduct well-controlled experiments) and
equity (i.e., fair and just distribution of resources and access). Therefore, the
current paper addresses one component of intervention research design: choosing a
comparator condition in clinical trials and other intervention studies in pediatric
psychology. The current paper aims to guide researchers to consider rigor and equity in
their selection of (1) trial design (i.e., whether a comparator condition is necessary),
and (2) the comparator condition itself (i.e., if a comparator condition is deemed
necessary, how to address both rigor and equity in the selection process). Previous work
has described processes for selecting comparator conditions with a focus on scientific
rigor (), but equity
considerations were not included. We advance the literature by considering both
scientific rigor and equity in trial design, with a focus on the selection of comparator
conditions.